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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00399477 |
Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Azilect (rasagiline mesylate) Drug: Mirapex Drug: Levodopa Drug: Requip |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) |
Estimated Enrollment: | 200 |
Study Start Date: | October 2006 |
Open-label, multicentered Two hundred-fifty (250) enrolled patients will be stratified within each center by absence/presence of concomitant dopaminergic therapy
PD symptom scales, satisfaction/ease-of-use ratings, global evaluations and safety assessments to be completed by investigator and/or patient at baseline and at specified visits during the study.
For patients receiving Azilect as adjunct therapy, the use and dose changes of LD/CD and /or dopamine agonists will be recorded in detail.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Requiring therapy for PD symptom control
Exclusion Criteria:
Study Director: | MerriKay Oleen-Burkey, PhD | Teva Neuroscience, Inc |
Study ID Numbers: | TVP-1012/PM101 |
Study First Received: | November 10, 2006 |
Last Updated: | July 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00399477 |
Health Authority: | United States: Institutional Review Board |
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